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Women clinical trials

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NCT ID: NCT03768986 Active, not recruiting - HIV Clinical Trials

A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

African American and Latina women, as well as women living in poverty, are an identified health disparities population for HIV. Risks for HIV are compounded in this population when additional risk factors are present, including other sexually transmitted infections, intimate partner violence, substance use disorders, and homelessness or housing insecurity. Knowledge of one's HIV serostatus is key to linkage to care, improving HIV outcomes, and decreasing the spread of HIV. However, roughly a third of African American women and over half of Latina women have never been tested (CDC, 2016a). Barriers to testing include socioeconomical inequality, racial discrimination, low health literacy, and inadequate access to quality healthcare, among others. Novel methods for increasing HIV testing in this important health disparities group are greatly needed. This study aims to test a reinforcement-based intervention to increase HIV testing and repeat testing among African American, Latina, and women living in poverty who have risk factors for HIV. We are partnering with multiple community-based organizations, several of which are non-traditional providers of HIV services (e.g., domestic violence agency, homeless shelter), to address systemic and structural issues that serve as barriers to testing. A primary aim is to evaluate the effectiveness of training community-based providers to deliver a reinforcement-based intervention for promoting HIV testing. In addition, we will compare standard referral services for HIV testing plus HIV risk reduction education to the same plus reinforcement for HIV testing (and repeat testing) using a randomized controlled trial with 334 participants. Women in both groups will be encouraged to seek HIV testing; be provided with the resources to do so (list of testing sites, bus passes if needed); and will receive basic education about HIV prevention using a widely available web-based resource (https://wwwn.cdc.gov/hivrisk/). Women in the reinforcement group will also be provided with $25 for undergoing an HIV test, with a $15 bonus if they have the test in the next 7 days ($40 total). During the next 12 months, they can receive an additional $25 for undergoing up to 2 more tests separated by 12 weeks, with $15 bonuses for each test completed within 7 days (+/- 7 days) of the scheduled date at 6- and 12-months post-initial test. It is hypothesized that the reinforcement intervention will result in greater proportions of women receiving an HIV test (and repeat HIV tests) compared to standard services. In the proposed study, approximately 50 clinicians from our partner sites will be trained on both the non-reinforcement and reinforcement approaches to increasing HIV testing. Primary clinician outcomes are clinician knowledge and attitudes about HIV, testing, and reinforcement interventions. These will be assessed pre- and post-training and at 6-month intervals thereafter. A secondary outcome is clinician satisfaction with the training. Once clinicians are trained to competence, 334 women at our partner agencies will be randomized. Participants will be assessed at baseline and at 3-, 9-, and 15-month follow-ups. The primary outcome is objective reports of HIV testing, verified by testing centers. Secondary outcomes are HIV risk behaviors, test results, self-efficacy, client attitudes towards testing, and HIV knowledge. In addition, this study will include a careful analysis of costs of the reinforcement intervention to allow for estimates of its cost-effectiveness in increasing HIV testing. The overall goal of this study is to determine whether a reinforcement intervention delivered by community providers is superior to standard referral procedures plus HIV education in increasing rates of HIV testing among women at the highest risk of HIV infection. A wide range of community partners that serve some of the highest risk groups of women were chosen to ensure highly generalizable results. If efficacious, the intervention has the potential for widespread adoption and implementation.

NCT ID: NCT03467347 Completed - Healthy Clinical Trials

PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

Start date: July 17, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.

NCT ID: NCT03438968 Recruiting - Clinical trials for Coronary Artery Disease

Women in Cardiac Rehabilitation: Optimizing the Training Response

Start date: August 24, 2017
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is highly prevalent in women resulting in 398,086 deaths annually. Even as women participate in traditional CR programs, data specificity and subsequent research have yet to emerge in a meaningful way so that women-centered CR can be better customized and their outcomes properly assessed. Aerobic fitness is a powerful predictor of prognosis in individuals with CVD yet there is evidence that women do not improve their peak VO2 as much as men during CR. We have designed a training program for women based upon past research with a goal of optimizing their training potential in CR. This program combines the utilization of a training technique termed high intensity interval training along with specific strength training exercises of the upper legs. We hypothesize that women, irrespective of age, would be capable of high intensity interval training to improve peak aerobic capacity in the CR setting. Furthermore, since women often have a deficit of thigh strength entering CR, and thigh strength correlates with endurance walking,strength training will also be included. The purpose of this study is to examine the value of high intensity interval training and strength training to maximize aerobic training response in CR for women. This may contribute to establishing specific protocols and training guidelines for future program design for women in CR. Since a set of comprehensive CR guidelines pertaining to women is lacking, it is hoped that the results of this study will help us develop exercise protocols and regimen to better structure and modulate CR programs for optimal benefit to women.

NCT ID: NCT03263923 Completed - Women Clinical Trials

The Grandmother Study: Grandmother Initiatives in Family Transformation

GIFT
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or younger, to take part in a study to compare methods of dealing with the stress of caregiving to grandchildren. Participants need to have daily access to a computer, complete four surveys online, and be willing to write in a journal every day for a month. Participants will be compensated for their time.

NCT ID: NCT03181607 Enrolling by invitation - Chronic Hepatitis b Clinical Trials

Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV

Start date: January 1, 2017
Phase:
Study type: Observational

Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF (tenofovir) or LDT(telbivudine) to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV. Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly. Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating. Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows: A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients. B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy. C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy. D, To compare MTCT rate and adverse effects between LDT and TDF.

NCT ID: NCT03099889 Active, not recruiting - Heart Failure Clinical Trials

WHISH-2-Prevent Heart Failure

Start date: April 15, 2015
Phase: N/A
Study type: Interventional

The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial examines the intervention effect of physical activity (PA) on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH trial is on atherosclerotic cardiovascular disease and not heart failure.

NCT ID: NCT02951949 Completed - Atherosclerosis Clinical Trials

Estrogen Exposure and Atherosclerosis in Postmenopausal Women

Start date: November 2014
Phase:
Study type: Observational

One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

NCT ID: NCT02700698 Completed - Healthy Clinical Trials

Mitochondrial Function in Circulating Cells and Muscle Tissue

MitoWomen
Start date: September 2016
Phase:
Study type: Observational

The main goal of this project is to determine whether mitochondrial function in circulating cells is related to that measured in the muscle fibers of the same subjects.

NCT ID: NCT01251887 Completed - Obesity Clinical Trials

Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition

Start date: November 12, 2010
Phase: N/A
Study type: Interventional

Background: - Rates of obesity have increased dramatically in recent decades, and researchers are investigating how changes in diets and physical activity have contributed to this increase. To understand how weight might be controlled, it is important to learn what kinds of dietary changes can affect hunger and might lower body weight. Essential fatty acids, for instance, are an important part of a healthy diet, but researchers have not yet determined the ideal amount of essential fatty acids that people should eat. By studying how different diets affect body chemistry and hormone levels in women who are overweight or obese, researchers hope to be able to determine better diets or treatments to help people reach and maintain an optimum healthy weight. Objectives: - To examine how certain fats in the diet affect body metabolism, hormones, and weight regulation. Eligibility: - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index between 25 and 35). Design: - This study has an initial screening visit and three phases. All participants will be involved in the first two phases of the study, and some participants will be involved in the third phase. - Participants will be screened with a physical examination and medical history, in addition to blood and urine tests and questionnaires about eating habits and other diet factors. - Phase 1: Participants will have three visits to the National Institutes of Health over a 4-week period. At the visits, participants will have blood and urine tests, complete questionnaires, and have other tests including brain and body imaging studies. Participants will then be assigned to one of three study diets. - Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the study researchers. Participants will keep a daily log of food and beverage intake, and will have three testing sessions with procedures similar to those performed in Phase 1. - Phase 3: Participants assigned to a particular study diet (one-third of all participants) will be given the option of continuing the diet for an additional 36 weeks (9 months), with food consumption, monitoring, and testing procedures similar to those performed in Phase 2....

NCT ID: NCT01241747 Completed - Clinical trials for Peripheral Artery Disease

Exercise for Women With Peripheral Arterial Disease

Start date: July 2009
Phase: N/A
Study type: Interventional

Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group. Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.